Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00006220

Trial Description

start of 1:1-Block title

Title

Support of pain therapy by continuous algesia measurements by A.N.I. monitor in postoperative patients at the recovery room

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

[---]*

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

Postoperative pain affects the recovery negatively, tends to become chronic and is an extremely unpleasant event for the patient. Therefore, the acute pain management is of great importance especially at the recovery room.
The acquisition of that subjective experience is difficult. Up to now, pain measurement is only possible by indicating pain intensity on a numeric rating scale. This conventional procedure will be performed in one study arm.
With the help of A.N.I. monitors it should be possible to determine an objective pain scale via the calculation of indices of various parameters, such as heart rate variability and the breathing pattern, which have a high correlation with the value on the NRS and can be charged regardless of the cooperation of the patient. In the second study arm, this device will be used.
The aim of this randomized controlled, single-blind study, is to investigate the suitability of the A.N.I. monitor to support the treatment of pain in the recovery room by means of comparing both study arms.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

The aim of our study is the evaluation of the suitability of the ANI-Monitor for continuous monitoring of algesia on postoperative patients in the recovery room.
The failure below the set limits of predetermined thresholds should help raise awareness of the staff in the recovery room. This should trigger questions by the staff about the patients pain sensations. The pain should be treated at an early stage, even before the patient expresses the pain spontaneously, as it often happens only at very intense pain (e.g. NRS>6). The total dose of aplicated analgesics and the average burden of pain (measured at middle NRS) can possibly be reduced for the patients.
Due to the higher constancy of an appropriate drug level possibly also the total amount of administered analgesics, and thus of adverse events is reduced.
Furthermore the common data of pulse oximetry will be charted, to be able to make a post hoc calculation of the SSI and to compare it with the ANI and the NRS.
As secondary target parameter there will be a questionnaire to document the feeling oft the patient and to compare it in both groups.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00006220
  •   2014/07/16
  •   [---]*
  •   yes
  •   Approved
  •   EK 041/14, Ethik-Kommission an der Medizinischen Fakultät der RWTH Aachen
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   postoperative pain
  •   R52.9 -  Pain, unspecified
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Continuous measurement by A.N.I. monitor additionally to periodically consultation of patients (every 15 minutes). A lower deviation of predetermined threshold (ANI ≤ 57) leads to the consultation of the patient about pain and if necessary to the application of analgesics.
  •   Conventional pain therapy by standards (consultation of NRS every 15 minutes, application of analgesics if necessary)
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Numeric Rating Score (average point value), measured pain intensity

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

Quantity of pain occurrence described by the patient during his stay in the recovery room, satisfaction of the patient (questionnaire after leaving the recovery room), duration of stay in the recovery room, total dose of applicated analgesics, incidence of adverse events in the recovery room (nausea, vomit, hypotension, hypertension, tachycardia, bradycardia), Aldrete-Score (charged every 15min), „Surgical Stress index“ (SSI)

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • [---]*
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2014/06/09
  •   150
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   111   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

1. not less than 18 years old, capable of giving consent
2. painful operative intervention, calculated minimum duration of 90 minutes
3. general anesthesia
4. planned postoperative stay in recovery room

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

beta blockers, cardiac pacemakers/ICD, catecholamine therapy, periduralcatheter (PDK), PCA pump (patient controlled analgesia), arrhythmias, bradypnea <9/min, heart transplant

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätsklinikum Aachen Klinik für Anästhesiologie
    • Mr.  PD Dr. med  Michael  Czaplik 
    • Pauwelsstr. 30
    • 52074  Aachen
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Universitätsklinikum Aachen Klinik für Anästhesiologie
    • Mr.  PD Dr. med  Michael  Czaplik 
    • Pauwelsstr. 30
    • 52074  Aachen
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Universitätsklinikum Aachen Klinik für Anästhesiologie
    • Mr.  PD Dr. med  Michael  Czaplik 
    • Pauwelsstr. 30
    • 52074  Aachen
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Universitätsklinikum Aachen Klinik für Anästhesiologie
    • Mr.  PD Dr. med  Michael  Czaplik 
    • Pauwelsstr. 30
    • 52074  Aachen
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up complete
  •   2016/07/01
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.